Manager QA Compliance

Vor 4 Tagen

Bern, Schweiz Emergent Biosolutions Vollzeit

Manager Quality Assurance Compliance & Validation (80 - 100%)

**Main responsibilities**:
Responsible, as QA representative in multidisciplinary teams, to oversee and review/approve qualification/validation documents and risk assessments for the following topics: Qualification of Equipment, Facilities, Utilities Computer System Validation (CSV)

**In this role the QA Manager**: drives the implementation of the qualification strategy supports the transfer from project into commercial production phase is the QA representative during qualification work ensures that the allocated quality-systems are compliant with regulatory expectations establishes and continuously improves quality procedures within the area of responsibility continuously improves the allocated quality systems supports changes and corrections for the area of responsibility participates in audits and inspection within the area of responsibility

**Qualification requirements**: Master’s degree in Engineering, Biotechnology, or related field. Minimum of 3 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry. Validation and Qualification experience required

Solid computer skills including MS Office required.

Analytical thinking and problem-solving attitude

Multilingual - at least German and English, written and spoken

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